Central Retinal Vein Occlusion
Conditions
Keywords
VEGF; BRVO; antibody
Brief summary
To evaluate the safety and efficacy of intravitreal recombinant humanized anti-VEGF monoclonal antibody in patients with visual impairment due to macular edema secondary to CRVO
Detailed description
Following a 14-day maximum screening period, patients will be randomized and followed for approximately 52 weeks. Treatment visits will be scheduled in 4-week intervals. After 6 initial monthly injections of 601 or ranibizumab (loading phase), subjects will enter an individualized flexible treatment (IFT) phase (week 24 to week 48). During the IFT phase, an assessment of disease stability will be performed at each monthly visit and subjects will receive either an injection or not. Safety and efficacy outcomes will continue to be evaluated up to a period of 52 weeks unless the patient is withdrawn or discontinues the study.
Interventions
DRUG601 1.25mg
Solution for injection (intravitreal use)
Solution for injection (intravitreal use)
Sponsors
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Sign informed consent form and willing to be visited at the time specified in the trial * Male or Female, at least 18 years of age * The study eye must meet the following criteria 1. Diagnosed with macular edema secondary to central retinal vein occlusion within 12 months 2. BCVA score between 78 and 19 letters, inclusive, using ETDRS visual acuity testing charts (approximate Snellen equivalent of 20/32 to 20/400) 3. CRT ≥ 250μm 4. No optometric media opacity and pupil abnormal * BCVA score ≥ 34 letters in the fellow eye, using ETDRS visual acuity testing charts (approximate Snellen equivalent of 20/200)
Exclusion criteria
For Study Eye: * Concomitant conditions or ocular disorders in the study eye at screening or baseline which could, in the opinion of the investigator, prevent response to study treatment or may confound interpretation of study results, compromise visual acuity or require medical or surgical intervention during the first 12-month study period (e.g. scarring, fibrosis or atrophy of the fovea, dense subfoveal hard exudates, significant hemorrhage obscuring the macular, vitreous hemorrhage, vitreomacular traction, retinal vascular occlusion other than CRVO, retinal detachment, macular hole, or age-related macular degeneration，choroidal neovascularization of any cause, diabetic retinopathy (except mild non-proliferative) and diabetic macular edema). Hemiretinal vein occlusion (HRVO) should be excluded * iris, chamber angle neovascularization or retinal, optic disc neovascularization * Previous use of intraocular or periocular steroids within 3 months prior to baseline, or previous use of dexamethasone intravitreal implant within 6 months prior to baseline * Macular laser photocoagulation (focal/grid)，panretinal laser photocoagulation，vitrectomy，radial optic neurotomy arteriovenous sheathotomy，trabeculectomy or keratoplasty in the study eye at any time prior to baseline. Local laser photocoagulation, YAG laser treatment or any other ocular surgeries (e.g. cataract surgery ) in the study eye within 3 months prior to the baseline * During the screening period, the BCVA is \>10 letters improved (the BCVA detected within 24 hours before the administration at day 0 compared with the BCVA at the screening) * Aphakia (except IOL) or posterior capsular defect (except YAG posterior capsulotomy after intraocular lens implantation surgery) For Any Eye: * Any eye has active ocular infections (e.g. blepharitis, conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) * Uncontrollable glaucoma (defined as intraocular pressure after antiglaucoma therapy\>= 25 mm Hg), or the cup/disk ratio \>0.8 in the study eye * History of intravitreal use of anti-VEGF drugs (e.g. ranibizumab，bevacizumab，aflibercept, conbercept, etc.) in any eye within 3 months prior to baseline General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in best-corrected visual acuity (BCVA) at Week 24 | Baseline to Week 24 | Assessed with ETDRS visual acuity testing charts. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of study eyes with a gain ≥ 5, 10 and 15 letters in BCVA by at Week 12, Week 24 and Week 52 compared to baseline | ：Baseline, Week 12, Week 24 and Week 52 | Assessed with ETDRS visual acuity testing charts. |
| Average Change of BCVA From Baseline to Week 4 Through Week 52 | Baseline to Week 52 | Assessed with ETDRS visual acuity testing charts. |
| Average Change of BCVA From Baseline to Week 28 Through Week 52 | Week 28 to Week 52 | Assessed with ETDRS visual acuity testing charts. |
| Change from baseline in central retina thickness (CRT) at Week 12, Week 24 and Week 52 | baseline, Week 12, Week 24 and Week 52 | OCT (optical coherence tomography) was used to assess central retina thickness (CRT) representing the average retinal thickness of the central 1 mm diameter subfield around the foveal center. |
| Number of injections from baseline to Week 52 | baseline to Week 52 | Number of administered injections |
| Change from baseline in BCVA by visit up to Week 12 and Week 52 | Baseline, Week 12 and Week 52 | Assessed with ETDRS visual acuity testing charts. |
| Incidence of ocular and non-ocular AEs up to Week 52 | Baseline to Week 52 | Incidence of ocular and non-ocular AEs |
| Blood concentrations of 601 at Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24，Week 36 and Week 52 | Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24，Week 36 and Week 52 | Steady-state blood concentrations of 601 |
| Blood concentrations of VEGF at Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24，Week 36 and Week 52 | Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24，Week 36 and Week 52 | Detection of VEGF blood concentration. |
| Immunogenicity of 601 at Baseline, Week 4, Week 12, Week 24, Week 36 and Week 52 | ：Baseline, Week 4, Week 12, Week 24, Week 36 and Week 52 | Detection of blood Anti-drug antibody (ADA) status. If ADA was positive, Neutralization antibody (Nab) will be tested. |
| Number of injections between Week 24 to Week 52 | Week 24 to Week 52 | Number of administered injections |
Countries
China
Outcome results
None listed